An observational study of patients receiving delayed-release budesonide (Nefecon) for immunoglobulin A nephropathy in the United States: A case series of Asian-American patients.

INTRODUCTION: IgA nephropathy (IgAN) is a leading cause of glomerulonephritis worldwide with variability by race and ethnicity. This study aimed to provide insights on the treatment journey and clinical outcomes in Asian-American patients with IgAN treated with delayed-release budesonide (Nefecon) in a real-world setting. MATERIALS AND METHODS: In this observational cohort study, a total of 45 consecutive patients with IgAN treated with Nefecon at Chinatown Kidney Care (CKC) (New York, NY, USA) were included. Study outcomes included treatment patterns and clinical outcomes (time to kidney failure, estimated glomerular filtration rate (eGFR), and urine protein-to-creatinine ratio (UPCR)). All variables were summarized descriptively. Subgroup analyses were performed among patients who were treated for ≥ 9 months vs. those treated for < 9 months. RESULTS: Overall, after 9 months of treatment, eGFR remained stable and UPCR decreased by an average of 19%. Improved clinical outcomes were reported among those who were treated for ≥ 9 months (preservation of eGFR and 26% reduction in UPCR) compared with those treated for < 9 months (decline in eGFR and ~ 3% reduction in UPCR). Nefecon was well tolerated with no severe or unexpected adverse events reported. CONCLUSION: Real-world IgA nephropathy treatment-associated outcomes with Nefecon in Asian-American patients for proteinuria and kidney function were consistent with those observed in the NefIgArd clinical trial. The reduction in proteinuria and improvement in kidney function was greater in patients who completed the 9-month course of therapy. These findings reveal an opportunity for further education among nephrologists regarding the recommended duration of treatment with Nefecon.